CN110430900B - 包含赛乐西帕的药物组合物 - Google Patents

包含赛乐西帕的药物组合物 Download PDF

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Publication number
CN110430900B
CN110430900B CN201880016540.5A CN201880016540A CN110430900B CN 110430900 B CN110430900 B CN 110430900B CN 201880016540 A CN201880016540 A CN 201880016540A CN 110430900 B CN110430900 B CN 110430900B
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China
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pharmaceutical composition
reconstituted
aqueous
lyophilized
compound
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Chinese (zh)
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CN110430900A (zh
Inventor
克劳斯·海勒布兰德
亚历山德拉·施利克尔-斯佩因
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Actelion Pharmaceuticals Ltd
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Actelion Pharmaceuticals Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/4965—Non-condensed pyrazines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CN201880016540.5A 2017-03-08 2018-03-07 包含赛乐西帕的药物组合物 Active CN110430900B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EPPCT/EP2017/055406 2017-03-08
EP2017055406 2017-03-08
PCT/EP2018/055551 WO2018162527A1 (en) 2017-03-08 2018-03-07 Pharmaceutical composition comprising selexipag

Publications (2)

Publication Number Publication Date
CN110430900A CN110430900A (zh) 2019-11-08
CN110430900B true CN110430900B (zh) 2023-09-19

Family

ID=61655736

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201880016540.5A Active CN110430900B (zh) 2017-03-08 2018-03-07 包含赛乐西帕的药物组合物

Country Status (27)

Country Link
US (1) US12121516B2 (ja)
EP (1) EP3592391B1 (ja)
JP (1) JP6964679B2 (ja)
KR (1) KR102593075B1 (ja)
CN (1) CN110430900B (ja)
AR (1) AR111570A1 (ja)
AU (1) AU2018229750B2 (ja)
BR (1) BR112019018420A2 (ja)
CA (1) CA3055010A1 (ja)
CL (1) CL2019002511A1 (ja)
CO (1) CO2019009221A2 (ja)
CR (1) CR20190455A (ja)
DO (1) DOP2019000250A (ja)
EA (1) EA201992074A1 (ja)
EC (1) ECSP19072294A (ja)
ES (1) ES2880009T3 (ja)
IL (1) IL269061A (ja)
JO (1) JOP20190204A1 (ja)
MA (1) MA47816A (ja)
MX (1) MX2019010598A (ja)
NI (1) NI201900090A (ja)
PE (1) PE20191492A1 (ja)
PH (1) PH12019502033A1 (ja)
PL (1) PL3592391T3 (ja)
SG (1) SG11201907804QA (ja)
TW (1) TWI764996B (ja)
WO (1) WO2018162527A1 (ja)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3965767A1 (en) * 2019-05-06 2022-03-16 Actelion Pharmaceuticals Ltd Methods for treating sarcoidosis-associated pulmonary hypertension
WO2020249602A1 (en) * 2019-06-11 2020-12-17 Actelion Pharmaceuticals Ltd Methods for treating pulmonary arterial hypertension
EP4048235A1 (en) * 2019-10-23 2022-08-31 Actelion Pharmaceuticals Ltd Pharmaceutical composition comprising selexipag
US20230113077A1 (en) 2020-01-31 2023-04-13 Actelion Pharmaceuticals Ltd Controlled release selexipag composition
TW202239408A (zh) 2021-01-29 2022-10-16 瑞士商艾克泰聯製藥有限公司 包含二苯基吡𠯤衍生物的醫藥組成物
WO2022215045A1 (en) * 2021-04-08 2022-10-13 Glenmark Pharmaceutical Limited Lyophilized composition comprising selexipag
WO2023131608A1 (en) 2022-01-04 2023-07-13 Actelion Pharmaceuticals Ltd Controlled release compositions
WO2023209731A1 (en) * 2022-04-25 2023-11-02 Msn Laboratories Private Limited, R&D Center Injectable liquid or lyophilized powder dosage forms of selexipag and their method of preparation
WO2023214059A1 (en) 2022-05-06 2023-11-09 Actelion Pharmaceuticals Ltd Diphenylpyrazine compounds as prodrugs
WO2023238952A1 (ja) * 2022-06-10 2023-12-14 日本新薬株式会社 医薬組成物
WO2024017964A1 (en) 2022-07-20 2024-01-25 Actelion Pharmaceuticals Ltd Injectable pharmaceutical composition comprising a diphenylpyrazine derivative
WO2024133620A1 (en) 2022-12-22 2024-06-27 Actelion Pharmaceuticals Ltd In vitro dissolution test
WO2024194449A1 (en) 2023-03-23 2024-09-26 Actelion Pharmaceuticals Ltd Pharmaceutical composition comprising a diphenylpyrazine derivative

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2893922A1 (en) * 2014-01-10 2015-07-15 Heart Biotech Pharma Limited Pharmaceutical formulations for the treatment of pulmonary arterial hypertension

Family Cites Families (17)

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TWI316055B (ja) 2001-04-26 2009-10-21 Nippon Shinyaku Co Ltd
EP1478339B9 (en) * 2002-02-22 2009-08-19 Schering Corporation Pharmaceutical formulations of antineoplastic agents, in particular temozolomide, processes of making and using the same
DK2246336T3 (da) 2008-02-28 2020-07-20 Nippon Shinyaku Co Ltd Fibroseinhibitor
WO2009154246A1 (ja) 2008-06-19 2009-12-23 日本新薬株式会社 勃起不全治療剤
EP2289518B1 (en) 2008-06-23 2016-11-02 Nippon Shinyaku Co., Ltd. Therapeutic agent for inflammatory bowel disease
CN105168218A (zh) 2008-06-23 2015-12-23 日本新药株式会社 椎管狭窄症治疗剂
WO2009157397A1 (ja) 2008-06-23 2009-12-30 日本新薬株式会社 非ステロイド性抗炎症剤投与に伴う腸管傷害治療剤
US8791122B2 (en) 2009-06-26 2014-07-29 Nippon Shinyaku Co., Ltd. Form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsulfonyl)acetamide and method for producing the same
WO2011024874A1 (ja) 2009-08-26 2011-03-03 日本新薬株式会社 塩基付加塩
KR20140053881A (ko) * 2011-04-19 2014-05-08 릭스하스피탈렛 모세관 누출의 예방 및 치료를 위한 수술 동안 투여되는 프로스타시클린 및 그 유사체
US9872864B2 (en) * 2011-08-12 2018-01-23 Ascendis Pharma A/S Sustained release composition of prostacyclin
JP6400479B2 (ja) 2012-10-29 2018-10-03 株式会社カルディオ 肺疾患特異的治療剤
CN110496099B (zh) 2013-09-11 2022-06-21 伊戈尔生物药品股份有限公司 包含粘度降低剂的液体蛋白质制剂
WO2017029594A1 (en) 2015-08-17 2017-02-23 Dr. Reddy's Laboratories Limited Processes for preparation of selexipag and its amorphous form
US10188648B2 (en) * 2015-09-03 2019-01-29 Teva Pharmaceuticals International Gmbh Solid state forms of selexipag
NZ742784A (en) 2015-12-02 2024-08-30 Nippon Shinyaku Co Ltd Pharmaceutical composition containing 2-{ 4-[n-(5,6- diphenylpyrazin-2-yl)-n-isopropylamino]butyloxy} -n- (methylsulfonyl)acetamide
EP3192502A1 (en) * 2016-01-15 2017-07-19 Sandoz Ag Pharmaceutical composition of selexipag

Patent Citations (1)

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EP2893922A1 (en) * 2014-01-10 2015-07-15 Heart Biotech Pharma Limited Pharmaceutical formulations for the treatment of pulmonary arterial hypertension

Non-Patent Citations (3)

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Title
Absolute oral bioavailability of selexipag, a novel oral prostacyclin IP receptor agonist;Priska Kaufmann等;《Eur J Clin Pharmacol》;20161124;第73卷(第2期);第151-156页 *
Pharmacokinetic drug evaluation of selexipag for the treatment of pulmonary arterial hypertension;Mayank Sardana等;《Expert Opinion on Drug Metabolism & Toxicology》;20161019;第12卷(第12期);第1-31页 *
Selexipag/ACT-293987 Pulmonary Arterial Hypertension Protocol AC-065A309;无;《https://clinicaltrials.gov/ProvidedDocs/78/NCT03187678/Prot_000.pdf》;20190419;第1-74页 *

Also Published As

Publication number Publication date
CR20190455A (es) 2019-11-12
EP3592391B1 (en) 2021-04-21
TWI764996B (zh) 2022-05-21
JP6964679B2 (ja) 2021-11-10
DOP2019000250A (es) 2020-09-15
ECSP19072294A (es) 2019-11-30
WO2018162527A1 (en) 2018-09-13
US20200129506A1 (en) 2020-04-30
EP3592391A1 (en) 2020-01-15
PL3592391T3 (pl) 2021-11-02
NI201900090A (es) 2020-03-11
KR20190122803A (ko) 2019-10-30
JOP20190204A1 (ar) 2019-09-05
ES2880009T3 (es) 2021-11-23
AU2018229750B2 (en) 2023-11-23
JP2020509070A (ja) 2020-03-26
EA201992074A1 (ru) 2020-02-27
CA3055010A1 (en) 2018-09-13
AR111570A1 (es) 2019-07-31
CN110430900A (zh) 2019-11-08
TW201842910A (zh) 2018-12-16
PH12019502033A1 (en) 2020-06-15
SG11201907804QA (en) 2019-09-27
MA47816A (fr) 2020-01-15
MX2019010598A (es) 2019-10-15
US12121516B2 (en) 2024-10-22
KR102593075B1 (ko) 2023-10-23
CO2019009221A2 (es) 2019-08-30
PE20191492A1 (es) 2019-10-21
AU2018229750A1 (en) 2019-09-12
BR112019018420A2 (pt) 2020-04-14
CL2019002511A1 (es) 2020-01-17
IL269061A (en) 2019-11-28

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